MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S 01.12.005 CEMENTLESS, SAND BLASTED STD STEM SIZE 5; HIP STEM CEMENTLESS

Model Number	01.12.005
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 12 years after the primary surgery, the surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 august 2022.Lot 092607: 15 items manufactured and released on 12-jan-2010.Expiration date: 2014-nov-30.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: batch review performed on 30 august 2022.Ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot 100916: 60 items manufactured and released on 23-apr-2010.Expiration date: 2015-mar-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Cup: versafitcup 01.26.50mb acetabular shell ø 50 (k083116) lot 101397: 39 items manufactured and released on 26-jul-2010.Expiration date: 2015-jun-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot 091555: 78 items manufactured and released on 29-jul-2009.Expiration date: 2014-may-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: QUADRA-S 01.12.005 CEMENTLESS, SAND BLASTED STD STEM SIZE 5
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15470267
• Report Number: 3005180920-2022-00710
• Device Sequence Number: 4322944
• Product Code: JDI
• UDI-Device Identifier: 07630030801860
• UDI-Public: 07630030801860
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 01.12.005
• Device Catalogue Number: 01.12.005
• Device Lot Number: 092607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male